# Medicare and Medicaid Programs; Quarterly Listing of Program IssuancesSecond Quarter, 1999

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A00-505

## Record

- **Collection:** Federal Register
- **Document type:** Notice
- **Published:** January 10, 2000
- **Citation:** 65 FR 1400

## Text

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-9005-N]

Medicare and Medicaid Programs; Quarterly Listing of Program
Issuances--Second Quarter, 1999

AGENCY: Health Care Financing Administration (HCFA), HHS.

[[Page 1401]]

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: This notice lists HCFA manual instructions, substantive and
interpretive regulations, and other Federal Register notices that were
published during April, May, and June of 1999, relating to the Medicare
and Medicaid programs. This notice also identifies certain devices with
investigational device exemption numbers approved by the Food and Drug
Administration that potentially may be covered under Medicare.
Section 1871(c) of the Social Security Act requires that we publish
a list of Medicare issuances in the Federal Register at least every 3
months. Although we are not mandated to do so by statute, for the sake
of completeness of the listing, we are also including all Medicaid
issuances and Medicare and Medicaid substantive and interpretive
regulations (proposed and final) published during this timeframe.

FOR FURTHER INFORMATION CONTACT: It is possible that an interested
party may have a specific information need and not be able to determine
from the listed information whether the issuance or regulation would
fulfill that need. Consequently, we are providing information contact
persons to answer general questions concerning these items. Copies are
not available through the contact persons.
Questions concerning Medicare items in Addendum III may be
addressed to Bridget Wilhite, Office of Communications and Operations
Support, Division of Regulations and Issuances, Health Care Financing
Administration, C5-16-03, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (410) 786-5248.
Questions concerning Medicaid items in Addendum III may be
addressed to Betty Stanton, Center for Medicaid State Operations,
Policy Coordination and Planning Group, Health Care Financing
Administration, S2-26-13, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (410) 786-3247.
Questions concerning Food and Drug Administration-approved
investigational device exemptions may be addressed to Sharon Hippler,
Office of Clinical Standards and Quality, Coverage and Analysis Group,
Health Care Financing Administration, C4-11-04, 7500 Security
Boulevard, Baltimore, MD 21244-1850, (410) 786-4633.
Questions concerning all other information may be addressed to
Trenesha Fultz, Office of Communications and Operations Support,
Division of Regulations and Issuances, Health Care Financing
Administration, C5-12-08, 7500 Security Boulevard, Baltimore, MD 21244-
1850, (410) 786-3822.

SUPPLEMENTARY INFORMATION:

I. Program Issuances

The Health Care Financing Administration (HCFA) is responsible for
administering the Medicare and Medicaid programs. These programs pay
for health care and related services for 39 million Medicare
beneficiaries and 35 million Medicaid recipients. Administration of
these programs involves (1) furnishing information to Medicare
beneficiaries and Medicaid recipients, health care providers, and the
public and (2) effective communications with regional offices, State
governments, State Medicaid Agencies, State Survey Agencies, various
providers of health care, fiscal intermediaries and carriers that
process claims and pay bills, and others. To implement the various
statutes on which the programs are based, we issue regulations under
the authority granted to the Secretary of the Department of Health and
Human Services under sections 1102, 1871, 1902, and related provisions
of the Social Security Act (the Act). We also issue various manuals,
memoranda, and statements necessary to administer the programs
efficiently.
Section 1871(c)(1) of the Act requires that we publish a list of
all Medicare manual instructions, interpretive rules, and guidelines of
general applicability not issued as regulations at least every 3 months
in the Federal Register. We published our first notice June 9, 1988 (53
FR 21730). Although we are not mandated to do so by statute, for the
sake of completeness of the listing of operational and policy
statements, we are continuing our practice of including Medicare
substantive and interpretive regulations (proposed and final) published
during the 3-month time frame.

II. How to Use the Addenda

This notice is organized so that a reader may review the subjects
of all manual issuances, memoranda, substantive and interpretive
regulations, or Food and Drug Administration-approved investigational
device exemptions published during the timeframe to determine whether
any are of particular interest. We expect it to be used in concert with
previously published notices. Those unfamiliar with a description of
our Medicare manuals may wish to review Table I of our first three
notices (53 FR 21730, 53 FR 36891, and 53 FR 50577) published in 1988,
and the notice published March 31, 1993 (58 FR 16837). Those desiring
information on the Medicare Coverage Issues Manual may wish to review
the August 21, 1989 publication (54 FR 34555).
To aid the reader, we have organized and divided this current
listing into five addenda:
Addendum I lists the publication dates of the most recent
quarterly listings of program issuances.
Addendum II identifies previous Federal Register documents
that contain a description of all previously published HCFA Medicare
and Medicaid manuals and memoranda.
Addendum III lists a unique HCFA transmittal number for
each instruction in our manuals or Program Memoranda and its subject
matter. A transmittal may consist of a single instruction or many.
Often, it is necessary to use information in a transmittal in
conjunction with information currently in the manuals.
Addendum IV lists all substantive and interpretive
Medicare and Medicaid regulations and general notices published in the
Federal Register during the quarter covered by this notice. For each
item we list the--
--Date published;
--Federal Register citation;
--Parts of the Code of Federal Regulations (CFR) that have changed
(if applicable);
--Agency file code number;
--Title of the regulation;
--Ending date of the comment period (if applicable); and
--Effective date (if applicable).
Addendum V includes listings of the Food and Drug
Administration-approved investigational device exemption numbers that
have been approved or revised during the quarter covered by this
notice. On September 19, 1995, we published a final rule (60 FR 48417)
establishing in regulations at 42 CFR 405.201 et seq. that certain
devices with an investigational device exemption approved by the Food
and Drug Administration and certain services related to those devices
may be covered under Medicare. It is our practice to announce all
investigational device exemption categorizations, using the
investigational device exemption numbers the Food and Drug
Administration assigns. The listings are organized according to the
categories to which the device numbers are assigned (that is, Category
A or Category B, and identified by the investigational device exemption
number).

III. How to Obtain Listed Material

A. Manuals

Those wishing to subscribe to program manuals should contact either

[[Page 1402]]

the Government Printing Office (GPO) or the National Technical
Information Service (NTIS) at the following addresses:

Superintendent of Documents, Government Printing Office, ATTN: New
Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954, Telephone (202)
512-1800, Fax number (202) 512-2250 (for credit card orders); or
National Technical Information Service, Department of Commerce, 5825
Port Royal Road, Springfield, VA 22161, Telephone (703) 487-4630.

In addition, individual manual transmittals and Program Memoranda
listed in this notice can be purchased from NTIS. Interested parties
should identify the transmittal(s) they want. GPO or NTIS can give
complete details on how to obtain the publications they sell.
Additionally, all manuals are available at the following Internet
address: http://www.hcfa.gov/pubforms/progman.htm.

B. Regulations and Notices

Regulations and notices are published in the daily Federal
Register. Interested individuals may purchase individual copies or
subscribe to the Federal Register by contacting the GPO at the address
given above. When ordering individual copies, it is necessary to cite
either the date of publication or the volume number and page number.
The Federal Register is also available on 24x microfiche and as an
online database through GPO Access. The online database is updated by 6
a.m. each day the Federal Register is published. The database includes
both text and graphics from Volume 59, Number 1 (January 2, 1994)
forward. Free public access is available on a Wide Area Information
Server (WAIS) through the Internet and via asynchronous dial-in.
Internet users can access the database by using the World Wide Web; the
Superintendent of Documents home page address is http://
www.access.gpo.gov/nara/index.html, by using local WAIS client
software, or by telnet to swais.access.gpo.gov, then log in as guest
(no password required). Dial-in users should use communications
software and modem to call (202) 512-1661; type swais, then log in as
guest (no password required).

C. Rulings

We publish rulings on an infrequent basis. Interested individuals
can obtain copies from the nearest HCFA Regional Office or review them
at the nearest regional depository library. We have, on occasion,
published rulings in the Federal Register. Rulings, beginning with
those released in 1995, are available online, through the HCFA Home
Page. The Internet address is http://www.hcfa.gov/regs/rulings.htm.

D. HCFA's Compact Disk-Read Only Memory (CD-ROM)

Our laws, regulations, and manuals are also available on CD-ROM and
may be purchased from GPO or NTIS on a subscription or single copy
basis. The Superintendent of Documents list ID is HCLRM, and the stock
number is 717-139-00000-3. The following material is on the CD-ROM
disk:
Titles XI, XVIII, and XIX of the Act.
HCFA-related regulations.
HCFA manuals and monthly revisions.
HCFA program memoranda.
The titles of the Compilation of the Social Security Laws are
current as of January 1, 1995. (Updated titles of the Social Security
Laws are available on the Internet at http://www.ssa.gov/OP__Home/
ssact/comp-toc.htm.) The remaining portions of CD-ROM are updated on a
monthly basis.
Because of complaints about the unreadability of the Appendices
(Interpretive Guidelines) in the State Operations Manual (SOM), as of
March 1995, we deleted these appendices from CD-ROM. We intend to re-
visit this issue in the near future and, with the aid of newer
technology, we may again be able to include the appendices on CD-ROM.
Any cost report forms incorporated in the manuals are included on
the CD-ROM disk as LOTUS files. LOTUS software is needed to view the
reports once the files have been copied to a personal computer disk.

IV. How to Review Listed Material

Transmittals or Program Memoranda can be reviewed at a local
Federal Depository Library (FDL). Under the FDL program, government
publications are sent to approximately 1,400 designated libraries
throughout the United States. Some FDLs may have arrangements to
transfer material to a local library not designated as an FDL. Contact
any library to locate the nearest FDL.
In addition, individuals may contact regional depository libraries
that receive and retain at least one copy of most Federal government
publications, either in printed or microfilm form, for use by the
general public. These libraries provide reference services and
interlibrary loans; however, they are not sales outlets. Individuals
may obtain information about the location of the nearest regional
depository library from any library.
Superintendent of Documents numbers for each HCFA publication are
shown in Addendum III, along with the HCFA publication and transmittal
numbers. To help FDLs locate the materials, use the Superintendent of
Documents number, plus the HCFA transmittal number. For example, to
find the Intermediary Manual, Part 1-Fiscal Administration (HCFA Pub.
13-1) transmittal entitled ``General,'' use the Superintendent of
Documents No. HE 22.8/6-3 and the HCFA transmittal number 129.

(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance, Program No. 93.774, Medicare--
Supplementary Medical Insurance Program, and Program No. 93.714,
Medical Assistance Program)

Dated: December 21, 1999.
Elizabeth Cusick,
Director, Office of Communications and Operations Support.

Addendum I

This addendum lists the publication dates of the most recent
quarterly listings of program issuances.

June 4, 1998 (63 FR 30499)
August 11, 1998 (63 FR 42857)
September 16, 1998 (63 FR 49598)
December 9, 1998 (63 FR 67899)
May 11, 1999 (64 FR 25351)
November 2, 1999 (64 FR 59185)
December 7, 1999 (64 FR 68357)

Addendum II

Description of Manuals, Memoranda, and HCFA Rulings

An extensive descriptive listing of Medicare manuals and memoranda
was published on June 9, 1988, at 53 FR 21730 and supplemented on
September 22, 1988, at 53 FR 36891 and December 16, 1988, at 53 FR
50577. Also, a complete description of the Medicare Coverage Issues
Manual was published on August 21, 1989, at 54 FR 34555. A brief
description of the various Medicaid manuals and memoranda that we
maintain was published on October 16, 1992 (57 FR 47468).

[[Page 1403]]

Addendum III.--Medicare and Medicaid Manual Instructions
[April 1999 through June 1999]
------------------------------------------------------------------------
Trans. No. Manual/Subject/Publication No.
------------------------------------------------------------------------
Intermediary Manual
Part 1--Fiscal Administration
(HCFA Pub. 13-1)
(Superintendent of Documents No. HE 22.8/6-3)
------------------------------------------------------------------------
129 <bulle General.
t
Instructions for Completing the HCFA-750A/B,
Contractor Financial Reports.
Due Date.
Certification.
Instructions for Completing the HCFA-751A/B,
Status of Accounts Receivable.
Line Item Instructions.
------------------------------------------------------------------------
Intermediary Manual
Part 2--Audits-Reimbursements Program Administration
(HCFA Pub. 13-2)
(Superintendent of Documents No. HE 22.8/6-2)
------------------------------------------------------------------------
412 <bulle List of Medical Review Codes, Categories, and
t Conversion Factors.
------------------------------------------------------------------------
Intermediary Manual
Part 3--Claims Process
(HCFA Pub. 13-3)
(Superintendent of Documents No. HE 22.8/6)
------------------------------------------------------------------------
1773 <bulle Screening Pap Smears and Screening Pelvic
t Examinations.
1774 <bulle Prostate Cancer Screening Tests and
t Procedures.
1775 <bulle Transmittal 1775 was omitted from the
t sequence and will never be released.
1776 <bulle HCFA Common Procedure Coding System for
t Hospital Outpatient Radiology Services and
Other Diagnostic Procedures.
1777 <bulle Payment for Blood Clotting Factor
t Administered to Hemophilia Inpatients.
------------------------------------------------------------------------
Carriers Manual
Part 1--Fiscal Administration
(HCFA Pub. 14-1)
(Superintendent of Documents No. HE 22.8/7-2)
------------------------------------------------------------------------
123 <bulle General.
t
Instructions for Completing the HCFA-750B,
Contractor Financial Reports.
Due Date.
Certification.
Instructions for Completing the HCFA-751A/B,
Status of Accounts Receivable.
Line Item Instructions.
------------------------------------------------------------------------
Carriers Manual
Part 3--Claims Process
(HCFA Pub. 14-3)
(Superintendent of Documents No. HE 22.8/7)
------------------------------------------------------------------------
1631 <bulle Area Carrier-Supplier's Services.
t
1632 <bulle Correct Coding Initiative.
t
1633 <bulle Positron Emission Tomography Scans.
t
...... Conditions of Coverage of Positron Emission
Tomography Scans for Recurrence of
Colorectal Cancer, Staging and
Characterization of Lymphoma, and Recurrence
of Melanoma.
Billing Requirements for Positron Emission
Tomography Scans.
...... HCFA Common Procedure Coding System and
Modifiers for Positron Emission Tomography
Scans.
Claims Processing Instructions for Positron
Emission Tomography Scan Claims.
1634 <bulle Pancreas Transplants.
t
Billing for Pancreas Transplants.
1635 <bulle Transmittal number 1635 was omitted from the
t sequence and will never be released.
1636 <bulle Chiropractors.
t
1637 <bulle Prostate Cancer Screening Tests and
t Procedures.
1638 <bulle Colorectal Cancer Screening.
t
1639 <bulle Private Contracts Between Beneficiaries and
t Physician/Practitioners.
General Rules of Private Contracts.
Effective Date of the Opt Out Provision.
Definition of Physician/Practitioners.
When a Physician or Practitioner Opts Out of
Medicare.
Definition of a Private Contract.
Physician or Practitioner Who Has Never
Enrolled in Medicare.
The Relationship Between This Provision and
Medicare Participation Agreements.
Participating Physicians and Practitioners.
Physicians or Practitioners Who Choose to Opt
Out of Medicare.

[[Page 1404]]

Maintaining Information on Opt Out
Physicians.
Informing Managed Care Plans Who the Opt Out
Physicians or Practitioners Are.
Informing the National Supplier Clearinghouse
Who the Opt Out Physicians or Practitioners
Are.
Organizations that Furnish Physician or
Practitioner Services.
Private Contracting Rules When Medicare is
the Secondary Payer.
System Identification.
Emergency and Urgent Care Situations.
Denial of Payment to Employers of Opt Out
Physicians and Practitioners.
Denial of Payment to Beneficiaries and
Others.
Payment of Medically Necessary Services
Ordered or Prescribed By an Opt Out
Physician or Practitioner.
Mandatory Claims Submission.
Claims Denial Notices to Opt Out Physicians
and Practitioners.
Claims Denial Notices to Beneficiaries.
Effect of Beneficiary Agreements Not to Use
Medicare Coverage.
When Payment May Be Made to a Beneficiary for
Service of an Opt Out Physician or
Practitioner.
Requirements of a Private Contract.
Requirements of the Opt Out Affidavit.
Failure to Properly Opt Out.
Failure to Maintain Opt Out.
Actions to be Taken in Cases of Failure to
Maintain Opt Out.
Non-Participating Physicians or Practitioners
Who Opt Out of Medicare.
Excluded Physicians and Practitioners.
Relationship to Non-Covered Services.
The Difference Between Advance Beneficiary
Notices.
Registration and Identification of Physicians
or Practitioners Who Opt Out.
Definition of Emergency and Urgent Care
Situations.
Renewal of Opt Out.
Early Termination of Opt Out.
Appeals.
Application to Medicare+Choice Contracts.
Reporting.
1640 <bulle Bone Mass Measurements.
t
1641 <bulle Medicare Participating Physician or Supplier
t Agreement.
------------------------------------------------------------------------
Carriers Manual
Part 4--Professional Relations
(HCFA Pub. 14-4)
(Superintendent of Documents No. HE 22.8/7)
------------------------------------------------------------------------
21 <bulle Appeals.
t
------------------------------------------------------------------------
Program Memorandum
Intermediaries (HCFA Pub. 60A)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
A-99-13 <bulle Reopenings for Sole Community Hospital and
t Medicare Dependent Hospital Cost Reports Due
to the Change to the Cost Report
Instructions in Calculating the Hospital-
Specific Amount on Form HCFA-2552-96 and
Form HCFA-2552-92.
A-99-14 <bulle Positron Emission Tomography Scans.
t
A-99-15 <bulle Cryosurgery of the Prostate Gland.
t
A-99-16 <bulle Claims Processing Instructions for Pancreas
t Transplantation.
A-99-17 <bulle Claims Processing Instructions for Cost
t Outlier Bills With Benefits Exhausted.
A-99-18 <bulle Clarification of Provider Cost Report Filing
t Requirements.
A-99-19 <bulle Removal of Edits Requiring Providers to
t Submit Home Health Claims in Sequence.
A-99-20 <bulle Payment Safeguard Review of Skilled Nursing
t Facility Prospective Payment Bills.
A-99-21 <bulle Claims Processing Instructions for Hospice
t Claims Received Out of Sequence.
A-99-22 <bulle Intermediary Review of Hospital Admission
t Questionnaires.
A-99-23 <bulle Managed Care Electronic Data Interchange
t Enrollment Form.
A-99-24 <bulle Policy Clarifications: Provider-Based
t Designation.
A-99-25 <bulle Extended Repayment Schedules for Home Health
t Agencies Affected by the Interim Payment
System.
A-99-26 <bulle Extension of Due Date for Filing Provider
t Cost Reports.
A-99-27 <bulle Home Health Agency Surety Bond Requirements.
t
A-99-28 <bulle Surety Bonds From Home Health Agencies.
t
A-99-29 <bulle Provider Education Information for Home
t Health Agencies--Regional Home Health
Intermediaries Only.
A-99-30 <bulle Provider Education Information for Home
t Health Agencies--Regional Home Health
Intermediaries Only.
------------------------------------------------------------------------
Program Memorandum
Carriers
(HCFA Pub. 60B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
B-99-13 <bulle Changes to Correct Coding Edits, Version 5.2,
t Effective July 1, 1999.

[[Page 1405]]

B-99-14 <bulle Reviewing Reassignment Agreements of Five or
t More.
B-99-15 <bulle Returns From Year 2000 Mailing.
t
B-99-16 <bulle Discontinuing the Use of Modifiers for
t Processing of Claims for Nurse
Practitioners, Physician Assistants, and
Clinical Nurse Specialists.
B-99-17 <bulle Establishment of Temporary National Modifiers
t to Allow Monitored Anesthesia Care for
Complex, Complicated, or Markedly Invasive
Surgical Procedures and for At Risk
Patients.
B-99-18 <bulle Adjustment in Payment Amounts for New
t Technology Intraocular Lenses Furnished by
Medicare Approved Ambulatory Surgical
Centers.
B-99-19 <bulle Extraction of HCFA Form-484 Certificate of
t Medical Necessity Data.
B-99-20 <bulle Durable Medical Equipment Regional Carriers
t Processing Claims When a Chiropractor is the
Supplier.
B-99-21 <bulle Establishment of Four Temporary National
t ``K'' Codes as Part of Planned Changes to
the Durable Medical Equipment Regional
Carriers Medical Review Policy on
Respiratory Assist Devices.
B-99-22 <bulle Correction of the Published National Standard
t Format Mapping for Remittance Advice.
B-99-23 <bulle Issues Involving Certificates of Medical
t Necessity and Cover Letters for Certificates
of Medical Necessity.
B-99-24 <bulle Changes to the 1999 Medicare Physician Fee
t Schedule Database.
B-99-25 <bulle Billing for Mammography Screening: Delay in
t Carrier Implementation and Coding
Clarification--Implementation of the GH
Modifier.
B-99-26 <bulle Claims Processing Instructions for
t Cryosurgery of the Prostate Gland.
B-99-27 <bulle Consent Settlement for Medical Review Audits.
t
B-99-28 <bulle Correction to Change Request 888 to Provide
t Changes to the 1999 Medicare Physician Fee
Schedule Database.
------------------------------------------------------------------------
Program Memorandum
Intermediaries/Carriers
(HCFA Pub. 60A/B)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
AB-99-12 <bulle Coverage of Testing for Hepatitis C in
t Patients Exposed to Infected Blood.
AB-99-13 <bulle Notification to Medicare Providers and
t Suppliers of Beneficiary Right to an
Itemized Statement.
AB-99-14 <bulle New Waived Tests.
t
AB-99-15 <bulle Medicare Coverage of Abortion Services.
t
AB-99-16 <bulle Changes to the FY 1999 Hospital Inpatient
t Operating Prospective Payment System Wage
Index Geographic and Standardized Amounts,
and Capital Prospective Payment System
Adjustment Factors and Federal Rates.
AB-99-17 <bulle Extension of the Limitation on Payment for
t Services to Individuals Entitled to Benefits
on the Basis of End Stage Renal Disease Who
Are Covered by Group Health Plans.
AB-99-18 <bulle Promoting Influenza and Pneumococcal
t Vaccinations.
AB-99-19 <bulle Expanded Implementation of the Office of the
t Inspector General's Fraud Hotline Number on
Medicare Beneficiary Notices, Effective July
1, 1999.
AB-99-20 <bulle Limited Medicare Coverage and Billing
t Instructions for Enhanced External
Counterpulsation.
AB-99-21 <bulle Claims Processing Instructions for Hyperbaric
t Oxygen Therapy.
AB-99-22 <bulle Transmyocardial Revascularization for
t Treatment of Severe Angina.
AB-99-23 <bulle Reimbursement for Ambulance Services to Non-
t hospital-Based Dialysis Facilities.
AB-99-24 <bulle Y2K--Data Match/MPARTS Mailout Record Layout.
t
AB-99-25 <bulle Beneficiary Right to Itemized Statement.
t
AB-99-26 <bulle Procedures for Write-Off and Adjustment/
t Reclassification of Medicare Contractor NON-
Medicare Secondary Payer Accounts
Receivable.
AB-99-27 <bulle Implementation of Calendar Year 2000 Fee
t Schedules and Pricing Updates.
AB-99-28 <bulle HCFA-1522, Monthly Contractor Financial
t Report, Reconciliation.
AB-99-29 <bulle Notice of New Interest Rate for Medicare
t Overpayments and Underpayments.
AB-99-30 <bulle Implementation of Sec. 4105 of the Balanced
t Budget Act Regarding Coverage of Diabetes
Outpatient Self-Management Training
Services.
AB-99-31 <bulle Assisted Suicide Funding Restriction Act of
t 1997 (P.L. 105-12).
AB-99-32 <bulle Claims Processing Instructions for Hyperbaric
t Oxygen Therapy.
AB-99-33 <bulle Tracking and Reporting Procedures for
t Unsolicited/Voluntary Refund Checks from
Providers/Suppliers-Interim Instructions.
AB-99-34 <bulle Intermediary and Carrier Billing and Claims
t Processing Instructions for Magnetic
Resonance Angiography.
AB-99-35 <bulle Current Status of Medicare Program Memoranda
t Issued Before Calendar Year 1999.
AB-99-36 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-37 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-38 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-39 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-40 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-41 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-42 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-43 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-44 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-45 <bulle Reserved for Y2K Contingency Planning
t Instructions.
AB-99-46 <bulle Coverage of Diabetes Outpatient Self-
t Management Training Services, Effective:
July 1, 1998.
AB-99-47 <bulle New Waived Tests--Effective Date of Receipt.
t
AB-99-48 <bulle Medicare Secondary Payer Denial Indicator and
t the Source Code Changes.
AB-99-49 <bulle Medicare Travel Allowance Fees for Collection
t of Specimens.
------------------------------------------------------------------------

[[Page 1406]]

Program Memorandum
Medicaid State Agencies
(HCFA Pub. 17)
(Superintendent of Documents No. HE 22.8/6-5)
------------------------------------------------------------------------
99-2 <bulle Current Status of Medicaid Program Memoranda
t and Action Transmittals Issued Before
Calendar Year 1999.
99-3 <bulle Title XIX of the Social Security Act,
t Elimination of Waste, Fraud and Abuse.
------------------------------------------------------------------------
Program Memorandum
Regional Offices--Standards and Certification
(HCFA Pub. 54)
(Superintendent of Documents No. HE 22.28/5:90-1)
------------------------------------------------------------------------
99-1 <bulle Civil Monetary Penalty Collection Procedures.
t
------------------------------------------------------------------------
State Operations Manual
Provider Certification
(HCFA Pub. 7)
(Superintendent of Documents No. HE 22.8/12)
------------------------------------------------------------------------
8 <bulle Resident Assessment in Long Term Care
t Facilities.
9 <bulle Medicare Rural Hospital Flexibility Program.
t
------------------------------------------------------------------------
Peer Review Organization Manual
(HCFA Pub. 19)
(Superintendent of Documents No. HE 22.8/8-15)
------------------------------------------------------------------------
71 <bulle Critical Access Hospital Acute Care Inpatient
t Stays Review.
72 <bulle Introduction.
t
Staffing Functions.
Mandatory System Use.
Operations.
Communication.
Confidentiality of System.
Applicable Documentation.
Process for Moving.
Standard Data Processing System Engineering
Review Board Process-Approved Software and
Hardware.
Hardware Maintenance Process.
Standard Data Processing System Data
Management Plan.
73 <bulle Request for Information Model Cover Letter.
t
Request for Information Model Form.
Final Response to Inquirer Model Notice
(Concern Involved Practitioner).
Final Response to Inquirer Model Notice
(Concern Involved Provider (Facility)).
Beneficiary Complaint Timetable for
Retrospective Review (Fee-for-Service and
Managed Care).
------------------------------------------------------------------------
Beneficiary Complaint Timetable for
Concurrent Review (Fee-for-Service and
Managed Care).
Hospital Manual
(HCFA Pub. 10)
(Superintendent of Documents No. HE 22.8/2)
------------------------------------------------------------------------
742 <bulle Screening Pap Smears and Screening Pelvic
t Examinations.
743 <bulle Payment for Blood Clotting Factor
t Administered to Hemophilia Inpatients.
744 <bulle Coding for Adequacy of Hemodialysis.
t
------------------------------------------------------------------------
End Stage Renal Disease
Network Organizations Manual
(HCFA Pub. 81)
(Superintendent of Documents No. HE 22.9/4)
------------------------------------------------------------------------
9 <bulle Background.
t
Definition.
Requirements.
Disagreements.
HCFA Office of Clinical Standards and Quality
Requirements.
Statutory and Regulatory Requirements.
Office of Management and Budget Clearance.
Items Not Subject to Office of Management and
Budget Clearance.
Request for Exception from Office of
Management and Budget Review.
Survey Justification and Methods.
Additional Considerations.
Documentation for HCFA.
------------------------------------------------------------------------

[[Page 1407]]

Coverage Issues Manual
(HCFA Pub. 6)
(Superintendent of Documents No. HE 22.8/14)
------------------------------------------------------------------------
109 <bulle Cardiac Output Monitoring by Electrical
t Bioimpedance.
Prostate Cancer Screening Tests.
110 <bulle Transmyocardial Revascularization for
t Treatment of Severe Angina.
Cryosurgery of the Prostate.
111 <bulle Enhanced External Counterpulsation.
t
112 <bulle Hyberbaric Oxygen Therapy.
t
113 <bulle Positron Emission Tomography Scans.
t
114 <bulle Vagus Nerve Stimulation for the Treatment of
t Seizures.
115 <bulle Pancreas Transplants.
t
Implantation of Automatic Defibrillators.
116 <bulle Home Use of Oxygen.
t
117 <bulle Magnetic Resonance Angiography.
t
------------------------------------------------------------------------
Provider Reimbursement Manual--Part 2
Provider Cost Reporting Forms and Instructions
Chapter 36--Form HCFA-2552-96
(HCFA Pub. 15-2-36)
(Superintendent of Documents No. HE 22.8/4)
------------------------------------------------------------------------
5 <bulle Hospital and Hospital Health Care Complex
t Cost Reporting Form.
------------------------------------------------------------------------
Provider Reimbursement Manual--Part 2
Provider Cost Reporting Forms and Instructions
Chapter 38--Form HCFA-1984-99
(HCFA Pub. 15-2-38)
(Superintendent of Documents No. HE 22.8/4)
------------------------------------------------------------------------
1 <bulle Hospice Cost Reporting Form.
t
------------------------------------------------------------------------
Medicare/Medicaid
Sanction--Reinstatement Report
(HCFA Pub. 69)
------------------------------------------------------------------------
99-3 <bulle Report of Physicians/Practitioners, Providers
t and/or Other Health Care Suppliers Excluded/
Reinstated-February 1999.
99-4 <bulle Report of Physicians/Practitioners, Providers
t and/or Other Health Care Suppliers Excluded/
Reinstated-March 1999.
99-5 <bulle Report of Physicians/Practitioners, Providers
t and/or Other Health Care Suppliers Excluded/
Reinstated-April 1999.
99-6 <bulle Report of Physicians/Practitioners, Providers
t and/or Other Health Care Suppliers Excluded/
Reinstated-May 1999.
------------------------------------------------------------------------

Addendum IV.--Regulation Documents Published in the Federal Register
--------------------------------------------------------------------------------------------------------------------------------------------------------
FR Vol. 64 End of comment
Publication Date Page CFR \1\ Part(s) File Code \2\ Regulation title period Effective date
--------------------------------------------------------------------------------------------------------------------------------------------------------
04/08/99 17184-17185 .................... HCFA-1071-N......... Medicare Program; April .................... ....................
23, 1999, Open Town Hall
Meeting to Discuss the
Skilled Nursing Facility
Prospective Payment
System (SNF/PPS) and
Quality of Care in
Nursing Facilities.
04/26/99 21196-21301 21 CFR Ch. 1; 42 CFR .................... Unified Agenda of Federal .................... ....................
Chs. I-V; and 45 Regulatory and
CFR Subtitle A, Deregulatory Actions.
Chs. II, III, and
XIII.
04/27/99 22619-22626 .................... HCFA-3432-GN........ Medicare Program; .................... 06/28/99
Procedures for Making
National Coverage
Decisions.
05/03/99 23653-23654 .................... HCFA-1101-N2........ Medicare Program; .................... ....................
Meetings of the
Competitive Pricing
Demonstration Area
Advisory Committee,
Maricopa County, AZ.

[[Page 1408]]

05/07/99 24550-24551 42 CFR Part 405..... HCFA-1002-N......... Medicare Program; .................... ....................
Meetings of the
Negotiated Rulemaking
Committee on Ambulance
Fee Schedule.
05/07/99 24716-24864 412, 413, 483, and HCFA-1053-N......... Medicare Program; Changes 07/06/99............
485. to the Hospital
Inpatient Prospective
Payment System and
Fiscal Year 2000 Rates.
05/10/99 24956-24957 498................. HCFA-3139-F......... Medicare Program and .................... 09/17/97
Medicaid Programs;
Effective Dates of
Provider Agreements and
Supplier Approvals;
Correction.
05/11/99 25351-25359 .................... HCFA-9000-N......... Medicare and Medicaid
Programs; Quarterly
Listing of Program
Issuances-Third Quarter,
1998.
05/12/99 25456-25460 405, 410, 413, 414, HCFA-1006-CN........ Medicare Program; .................... 01/01/99
415, 424, and 485. Revisions to Payment
Policies and Adjustments
to the Relative Value
Units Under the
Physician Fee Schedule
for Calendar Year 1999;
Correction.
05/14/99 26426-26427 .................... HCFA-1072-N......... Medicare Program; June
14, 1999, Meeting of the
Practicing Physicians
Advisory Council.
05/28/99 29186-29188 45 CFR Subtitle A... .................... Coverage for Breast 06/28/99............
Reconstruction and
Related Services After a
Mastectomy.
06/04/99 30042-30043 .................... HCFA-1075-N......... Medicare Program; June
25, 1999, Public Meeting
To Discuss the Payment
Classification for
Respiratory Assist
Devices.
06/09/99 31006-31007 .................... HCFA-1080-N......... Medicare Program; Meeting
of the Competitive
Pricing Demonstration
Area Advisory Committee,
Maricopa County, AZ.
06/10/99 31281-31282 .................... HCFA-1081-N......... Medicare Program; June
24, 1999, Meeting of the
Competitive Pricing
Advisory Committee and
the Area Advisory
Committee for the Kansas
City Metropolitan Area.
06/15/99 31995-32021 412, 413, 483, and HCFA-1053-CN........ Medicare Program; Changes
485. to the Hospital
Inpatient Prospective
Payment Systems and
Fiscal Year 2000 Rates;
Correction.
06/16/99 32198-32206 416................. HCFA-3831-F......... Medicare Program; .................... 07/16/99
Adjustment in Payment
Amounts for New
Technology Intraocular
Lenses Furnished by
Ambulatory Surgical
Centers.
06/18/99 32881-32886 .................... HCFA-2039-FN........ Medicare Program; .................... 06/18/99-06/18/03
Recognition of the Joint
Commission for
Accreditation of
Healthcare Organizations
(JCAHO) for Hospices.
06/18/99 32983-32991 .................... HCFA-3020-N......... Medicare and Medicaid .................... 07/19/99
Programs; Mandatory Use,
Collection, Encoding,
and Transmission of
Outcome and As sessment
Information Set (OASIS)
for Home Health Agencies.

[[Page 1409]]

06/18/99 32992-32998 .................... .................... Privacy Act of 1974; .................... 06/18/99 or 07/28/99
Report of New System.
06/22/99 33314-33315 .................... HCFA-1081-2N........ Medicare Program;
Cancellation of the June
24, 1999, Meeting of the
Competitive Pricing
Advisory Committee and
the Area Advisory
Committee for the Kansas
City Metropolitan Area.
06/30/99 35257-35513 409, 410, 411, 412, HCFA-1005-CN........ Medicare Program;
413, 419, 489, 498, Prospective Payment for
and 1003. Hospital Outpatient
Services; Correction;
Proposed Rule.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 42 CFR except where noted.
\2\ N--General Notice; PN--Proposed Notice; NC--Notice with Comment Period; FN--Final Notice; P--Notice of Proposed Rulemaking (NPRM); F--Final Rule;
FC--Final Rule with Comment Period; CN--Correction Notice; IFC--Interim Final Rule with Comment Period; GNC--General Notice with Comment Period.

Addendum V

Categorization of Food and Drug Administration--Allowed
Investigational Device Exemptions

Under the Food, Drug, and Cosmetic Act (21 U.S.C. 360c), devices
fall into one of three classes. Also, under the new categorization
process to assist HCFA, the Food and Drug Administration assigns each
device with a Food and Drug Administration-approved investigational
device exemption to one of two categories. To obtain more information
about the classes or categories, please refer to the Federal Register
notice published on April 21, 1997 (62 FR 19328).
The following information presents the device number, category (in
this case, A), and criterion code.

G940094 A1
G940156 A1
G970104 A1
G970204 A1
G980179 A2
G980283 A1
G990056 A1
G990062 A2
G990071 A1

The following information presents the device number, category (in
this case, B), and criterion code.

G980237 B2
G980258 B2
G980317 B1
G980329 B2
G990002 B2
G990013 B2
G990018 B2
G990027 B3
G990059 B3
G990063 B4
G990065 B4
G990072 B1
G990073 B
G990079 B2
G990081 B3
G990082 B2
G990086 B4
G990087 B4
G990088 B2
G990090 B4
G990091 B4
G990093 B2
G990095 B4
G990096 B3
G990098 B4
G990099 B2
G990106 B2
G990109 B4
G990115 B3
G990117 B1
G990119 B4
G990136 B3

[FR Doc. 00-505 Filed 1-7-00; 8:45 am]
BILLING CODE 4120-01-P

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A00-505. Public record. Not legal advice.
